The GIRO Growth Modulation System

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Pega Medical, Inc.

The following data is part of a premarket notification filed by Pega Medical, Inc. with the FDA for The Giro Growth Modulation System.

Pre-market Notification Details

• Device ID: K220190
• 510k Number: K220190
• Device Name: The GIRO Growth Modulation System
• Classification: Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
• Applicant: Pega Medical, Inc. 1111 Autoroute Chomedey Laval, CA H7W 5J8
• Contact: Ariel R. Dujovne
• Correspondent: Ariel R. Dujovne; Pega Medical, Inc. 1111 Autoroute Chomedey Laval, CA H7W 5J8
• Product Code: OBT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-01-24
• Decision Date: 2022-10-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07540194013682	K220190	000
07540194013552	K220190	000
07540194013545	K220190	000
07540194013538	K220190	000
07540194013521	K220190	000
07540194013514	K220190	000
07540194013507	K220190	000
07540194013491	K220190	000
07540194013484	K220190	000
07540194014726	K220190	000
07540194013569	K220190	000
07540194013576	K220190	000
07540194013583	K220190	000
07540194013675	K220190	000
07540194013668	K220190	000
07540194013651	K220190	000
07540194013644	K220190	000
07540194013637	K220190	000
07540194013620	K220190	000
07540194013613	K220190	000
07540194013606	K220190	000
07540194013590	K220190	000
07540194014719	K220190	000
07540194014702	K220190	000
07540194014696	K220190	000
07540194014375	K220190	000
07540194014368	K220190	000
07540194014351	K220190	000
07540194014344	K220190	000
07540194014337	K220190	000
07540194014320	K220190	000
07540194014313	K220190	000
07540194014306	K220190	000
07540194014290	K220190	000
07540194014382	K220190	000
07540194014399	K220190	000
07540194014405	K220190	000
07540194014689	K220190	000
07540194014672	K220190	000
07540194014665	K220190	000
07540194014658	K220190	000
07540194014641	K220190	000
07540194014634	K220190	000
07540194014627	K220190	000
07540194014610	K220190	000
07540194014603	K220190	000
07540194014283	K220190	000
07540194014887	K220190	000
07540194014757	K220190	000
07540194014740	K220190	000
07540194014733	K220190	000
07540194014597	K220190	000
07540194014580	K220190	000
07540194014573	K220190	000
07540194014566	K220190	000
07540194014559	K220190	000
07540194014542	K220190	000
07540194014764	K220190	000
07540194014771	K220190	000
07540194014788	K220190	000
07540194014870	K220190	000
07540194014863	K220190	000
07540194014856	K220190	000
07540194014849	K220190	000
07540194014832	K220190	000
07540194014825	K220190	000
07540194014818	K220190	000
07540194014801	K220190	000
07540194014795	K220190	000
07540194014535	K220190	000
07540194014528	K220190	000
07540194014511	K220190	000
07540194015181	K220190	000
07540194015174	K220190	000
07540194015167	K220190	000
07540194014252	K220190	000
07540194013743	K220190	000
07540194013736	K220190	000
07540194013729	K220190	000
07540194013712	K220190	000
07540194013705	K220190	000
07540194014269	K220190	000
07540194014276	K220190	000
07540194014412	K220190	000
07540194014504	K220190	000
07540194014498	K220190	000
07540194014481	K220190	000
07540194014474	K220190	000
07540194014467	K220190	000
07540194014450	K220190	000
07540194014443	K220190	000
07540194014436	K220190	000
07540194014429	K220190	000
07540194013699	K220190	000